MAUDE Adverse Event Report: . G7 SCREW; PROSTHESIS, HIP

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Event occurred in (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during inspection of the product part of the sterile package was not sealed properly.There was no patient involvement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The visual inspection of the returned product identified voids within the seal of the sterile pouch.Dhr was reviewed and no discrepancies were found.Review of complaints history search for identified no other complaints reported for the same lot.The likely condition of the product when it left zimmer biomet was non-conforming.The root-cause of the reported event is the operator not following instructions during the manufacturing process.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: G7 SCREW
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): .; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8173579
• MDR Text Key: 130637809
• Report Number: 0001825034-2018-11360
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000997
• Device Lot Number: 6425085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1